Electrical stimulation device and method for therapeutic treatment and pain management

ABSTRACT

A disposable electrical stimulation device and method for providing therapeutic treatment and pain management in a convenient, compact configuration. Electrode size and shape and relative configuration can be varied according to an intended application and use, or a universal configuration can be provided for use on almost any area of the body. The common structure of communicatively coupled dual electrodes including control circuitry and a power source accommodates a range of different sizes, configurations, stimulation treatment intensities, and other physical and electrical characteristics that can be pre-customized and packaged for specific, limited time use. The device can therefore be used in methods of providing therapy, managing pain, and achieving other treatment goals by electrical stimulation.

INCORPORATION BY REFERENCE TO RELATED APPLICATIONS

Any and all priority claims identified in the Application Data Sheet, orany correction thereto, are hereby incorporated by reference under 37CFR 1.57. This application is a continuation of U.S. application Ser.No. 11/918,761 filed Nov. 5, 2009, which is the national phase under 35U.S.C. §371 of prior PCT International Application No. PCT/US2006/014734which has an International Filing Date of Apr. 19, 2006, whichdesignates the United States of America, and which claims priority toU.S. Provisional Application No. 60/672,937 filed Apr. 19, 2005. Each ofthe aforementioned applications is incorporated by reference herein inits entirety, and each is hereby expressly made a part of thisspecification.

FIELD OF THE INVENTION

The invention relates generally to electrical stimulation for medicalpurposes. More particularly, the invention is directed to a compactelectrical stimulation device and method for controlling and blockingeveryday pain.

BACKGROUND OF THE INVENTION

It is common practice for therapists, physicians, athletes, and otherindividuals to utilize various electrical stimulation treatment andtherapy devices to promote muscle training, conditioning, and growth. Inaddition, devices often referred to as transcutaneous electrical nervestimulation (“TENS”) and microcurrent therapy units are employed toalleviate or eliminate pain and discomfort by blocking nerve signalsfrom an affected area to the brain.

In pain management applications, electrical stimulation devices are usedprimarily to alleviate pain and discomfort, including chronicintractable pain, post-surgical pain, and post traumatic pain, and toincrease blood flow. Increasing blood flow, for example, fostershealing. TENS, microcurrent, and other electrotherapy stimulationtechniques have been used successfully for the symptomatic relief andmanagement of chronic intractable pain for many years. In general, TENSor microcurrent electrical nerve stimulation controls pain of peripheralorigin by providing a counter stimulation that interferes with thepainful sensations.

For example, in one application of electrical stimulation according togate control theory, small electrical impulses are sent through the skininto a painful area. These electrical impulses are harmless but reachthe nerves and cause a mild tingling sensation. Gate control theoryprovides that as pain impulses travel through a nerve to the spinal cordand brain, the pain impulses can be altered or modified at certainpoints along the route. Pain signals are carried to the brain via smalldiameter, slow conducting nerve fibers. This transmission can be blockedby stimulating larger diameter, fast conducting nerve fibers. Thesignals traveling along the fast conducting nerve fibers normally reachthe brain before those traveling along the slow conducting nerve fibers.If the larger fibers are stimulated without much activity of the smallerpain fibers, the “gate” is closed and pain is lessened and/or blocked.

Existing electrical stimulation devices used primarily to alleviatemuscle pain or other discomfort, or to otherwise provide therapeutictreatment, typically comprise a stimulation unit coupled to an electrodeor set of electrodes adapted to deliver stimulation treatment to thetissue of a user. Stimulation units can be large, table-top orfreestanding devices, or relatively small, handheld or belt-mounteddevices that are more easily portable. In either case, the units aregenerally used for some period of time, perhaps several minutes to aboutan hour, and then stored away when not in use. Many also requiresupervised use and treatment by a medical professional.

U.S. Pat. Nos. 6,002,965 and 6,282,448 disclose self applied devices andmethods for prevention of deep vein thrombosis. The devices comprise anelongated rectangular cuff having fasteners and electrodes with anattached control unit for providing a predetermined electrical signal tothe electrodes. The electrodes can also be combined with a motiondetector for detecting muscle contraction.

Microcurrent and other therapeutic devices used for pain management areknown in patch or bandage form, which are typically less obtrusive andexpensive than the aforementioned stimulation units. These devices caneasily be worn under clothing or otherwise applied to a user's tissueand left on for longer periods of time, from an hour to two or moredays. The period of time for which such a microcurrent device can beleft is typically dictated by the power source included with the device.While some microcurrent devices can receive power from independent andexternal sources, other microcurrent devices include an on-board powersource, such as a coin-type battery.

For example, U.S. Pat. Nos. 6,408,211 and 6,606,519 teach microcurrenttherapy devices for use in applying a DC current of less than onemilliampere between two conductive pads through the tissue of a therapyrecipient. The device can include an indicator such as an LED to providean indication of imperceptible current flow, as taught by U.S. Pat. No.6,408,211. Other microcurrent therapy devices and/or patch orbandage-type devices are disclosed in U.S. Pat. Nos. 3,472,233;4,398,545; 4,982,742; 5,423,874; 5,578,065; 6,285,899; and 6,631,294.

Existing electrical stimulation devices, in particular those for painmanagement and control, suffer from several drawbacks. Microcurrentdevices, while typically unobtrusive and convenient to use, generally donot excite nerves or stimulate muscles and therefore cannot provide thesensation and healing of TENS or other stimulation devices. Large andhandheld devices, however, are cumbersome and do not provide extendedtreatment times in an unobtrusive and inexpensive manner. These devicesalso typically require a prescription or monitored use by a physician orother medical professional. Patch and bandage-type devices can offermore convenience, although the increased convenience typically comes ata higher cost. Further, patch and bandage-type devices do not providecontrol options; these devices instead deliver one treatment mode andintensity with no customization between on or off, or treatmentarea-specific modes or varieties.

Accordingly, for these and other reasons, a need exists in the industryfor an inexpensive, compact, and controllable electrical stimulationdevice and method for therapeutic treatment and pain management.

SUMMARY OF THE DISCLOSURE

The present invention solves many of the above described deficienciesand drawbacks inherent with conventional TENS and microcurrent therapydevices and treatments. In particular, various embodiments of theinvention are directed to a compact electrical stimulation device and amethod of providing electrical stimulation. In one embodiment, theelectrical stimulation device comprises a TENS-based stimulator havingfirst and second electrodes, first and second electrode zones, or firstand second conductive flexible circuit boards for therapeutic treatmentand blocking of pain associated with everyday tasks. In anotherembodiment, the electrical stimulation device can be used as a massagedevice or muscle stimulator for goals other than pain management, incombination with or without TENS-based stimulation.

According to one aspect of the invention, the electrical stimulationdevice is compact, with the control circuitry and power source containedwithin the electrode(s). In one embodiment, both the electroniccircuitry and the power source are embedded within one electrode. Inanother embodiment, the circuitry and power source are within separateelectrodes. In yet another embodiment, the control circuitry is enclosedwithin a control module that can be removably coupled to an electrode.In this embodiment, the power source can be located within the controlmodule, embedded in an electrode, or removably coupled to an electrode.The power source is preferably one or more batteries, and both thecontrol circuitry and power source are preferably inaccessible to auser.

According to one embodiment of the invention, the electrical stimulationdevice comprises a disposable dual electrode configuration. Theelectrical stimulation device is adapted to be temporarily affixed tothe skin of a user proximate a target tissue treatment area and, in oneembodiment, automatically commences treatment upon placement. Apreprogrammed treatment program according to this embodiment graduallyincreases stimulation intensity to a predefined fixed maximum level andmaintains electrical stimulation therapy until the device is removedfrom a user's skin or a power source is fully depleted. In oneembodiment, the power source comprises at least one non-replaceablebattery embedded in one or both of the electrodes and has an expectedlife in continuous use of several hours, typically about twelve hourswith a preset intensity level setting. The power source can also bereplaceable or rechargeable. After treatment, the electrical stimulationdevice is fully or partially disposable. In partially disposableembodiments, the electrodes can be disposed of while at least a portionof the control module is reusable. In a fully disposable embodiment, theentire device is non-reusable following depletion of the power source.

According to another embodiment of the invention, the electricalstimulation device further comprises a control button and a statusindicator on at least one electrode. The control button can comprise anON/OFF button, an ON/ADJUST/OFF button, a toggle button, or a pluralbutton configuration. A plural button configuration enables a user toeasily and tactilely differentiate between two or more buttons, such aswhen the electrical stimulation device is positioned on a user's back orother out-of-sight area. In one embodiment, the control button isrecessed to prevent accidental activation of the button and also toprevent any metallic contact when a user depresses the button. When theelectrical stimulation device is powered on and an ON/ADJUST/OFF buttonis held, the stimulation intensity can increase until the button isreleased, up to a preset maximum. When the electrical stimulation deviceis powered on and a toggle button is depressed, the stimulationintensity step increases to a preset maximum or step decreases to apreset minimum with each depression. In one embodiment, the electricalstimulation device preferably includes several different intensitysettings. In another embodiment, the electrical stimulation deviceprovides a continuous ramping up of intensity to a preset maximum. Inyet another embodiment, the electrical stimulation device provides asingle intensity. In one embodiment, the status indicator is alight-emitting diode (LED). The indicator is preferably illuminated,steady or blinking, when the device is powered on and power source lifeexists.

Preferred embodiments of the electrical stimulation device of theinvention thereby can provide compact and convenient therapeutictreatment devices. The common structure of communicatively coupled dualelectrodes including embedded or enclosed circuitry and a power sourceaccommodates a range of different sizes, configurations, stimulationtreatment intensities, and other physical and electrical characteristicsthat can be pre-customized and packaged for specific use.

The device can therefore be used in methods of providing therapy,managing pain, and achieving other treatment goals by electricalstimulation. In particular, one method of providing electricalstimulation therapy thereby can comprise offering a range of variouselectrical stimulation devices, each customized for a desiredtherapeutic treatment and/or region of the body, that are inexpensive,unobtrusive, easy to use, and partially or completely disposable. Eachdevice of the range can be packaged for easy identification andselection by a user according to a particular need.

The above summary of the invention is not intended to describe eachillustrated embodiment or every implementation of the present invention.The figures and the detailed description that follow more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of thefollowing detailed description of various embodiments of the inventionin connection with the accompanying drawings, in which:

FIG. 1 is a top view of an electrical stimulation device according toone embodiment of the invention.

FIG. 2A is a top view of an electrical stimulation device according toone embodiment of the invention.

FIG. 2B is a side view of the electrical stimulation device of FIG. 2A.

FIG. 3 is a top perspective view of an electrical stimulation deviceaccording to one embodiment of the invention.

FIG. 4 is a top view of an electrical stimulation device according toone embodiment of the invention.

FIG. 5 is a top view of an electrical stimulation device according toone embodiment of the invention.

FIG. 6 is an enlarged top perspective view of a keypad according to oneembodiment of the invention.

FIG. 7A is a top view of an electrical stimulation device according toone embodiment of the invention.

FIG. 7B is a top view of one embodiment of a control module of theelectrical stimulation device of FIG. 7A.

FIG. 7C is a top view of another embodiment of a control module of theelectrical stimulation device of FIG. 7A.

FIG. 7D is a top view of another embodiment of a control module of theelectrical stimulation device of FIG. 7A.

FIG. 7E is a top view of another embodiment of a control module of theelectrical stimulation device of FIG. 7A.

FIG. 7F is a top view of another embodiment of a control module of theelectrical stimulation device of FIG. 7A.

FIG. 8A is a perspective view of an electrical stimulation deviceaccording to one embodiment of the invention, depicting a snapattachment feature.

FIG. 8B is a perspective view of another embodiment of the electricalstimulation device of FIG. 8A, depicting another snap attachmentfeature.

FIG. 9 is a side cross-sectional view of a control module according toone embodiment of the invention.

FIG. 10A is a top perspective view of the control module of FIG. 9A.

FIG. 10B is a bottom perspective view of the control module of FIGS. 9and 10A.

FIG. 11 is a side cross-sectional view of a control module housingaccording to one embodiment of the invention.

FIGS. 12A-C are diagrams of a plurality of conductive zones according toone embodiment of the invention.

FIG. 13 is a side view of an electrical stimulation device according toone embodiment of the invention.

FIG. 14A is a top view of the electrical stimulation device of FIG. 13.

FIG. 14B is another side view of the electrical stimulation device ofFIGS. 13 and 14A.

FIG. 14C is a bottom view of the electrical stimulation device of FIGS.13, 14A, and 14B.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit the invention to theparticular embodiments described. On the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION OF THE INVENTION

The electrical stimulation device and method according to the inventionprovide inexpensive and convenient therapeutic treatment and painmanagement. The invention can be more readily understood by reference toFIGS. 1-14C and the following description. While the invention is notnecessarily limited to such an application, the invention will be betterappreciated using a discussion of exemplary embodiments in specificcontexts.

Referring to FIG. 1, an electrical stimulation device 20 comprises anautomatic and, in one embodiment, disposable dual electrodeconfiguration. A first electrode 22 and a second electrode 24 arephysically and electrically coupled by a flexible cable or lead wire 26.This dual electrode configuration enables placement of device 10 on manydifferent parts of the body to provide electrical stimulation fortherapeutic treatment and pain management. To this end, the size andshape of electrodes 22 and 24, and the length of lead wire 26, can varyto more easily conform to a particular area of the body. For example,while substantially square or rectangular electrodes may be suited tothe abdomen and back, round, oblong, or substantially I-shapedelectrodes may better conform to the shoulders, arms, legs, and otherareas of the body. In one example embodiment, electrodes 22 and 24 areapproximately two inches, or about five centimeters, square, and leadwire 26 is about six inches, or about fifteen centimeters, long. Inanother embodiment, electrodes 22 and 24 are each about two (inches)wide and about four inches long, or about five centimeters by about tencentimeters. Electrodes 22 and 24 preferably have a low profile, i.e.,are as thin as possible, to remain unobtrusive and invisible when worn,for example, under clothing.

A first surface of each first electrode 22 and second electrode 24preferably includes an adhesive layer 28 adapted to temporarily affixeach electrode 22 and 24 to a user's skin for treatment. In onepreferred embodiment, adhesive layer 28 comprises a material that canmaintain adherence to a user's skin for a treatment session of a fewminutes to several hours or more, withstand movement by the user duringthe treatment session, and is substantially waterproof yet easily andpainlessly removable by a user after treatment. In another preferredembodiment, adhesive layer 28 further comprises a reusable adhesivematerial such that a user can apply electrodes 22 and 24 for a firsttreatment session, selectively remove electrodes 22 and 14, and laterreapply electrodes 22 and 24 for a second treatment session. Adhesivelayer 28 may also include a topical agent, for example menthol orcapsaicin, that provides an initial, non-iontophoretic warming orcooling sensation to a user's skin upon application and contact tofurther alleviate pain.

In another embodiment of device 20 depicted in FIG. 2, electrodes 22 and24 and lead wire 26 are incorporated into a single structure 30. In thisembodiment, structure 30 comprises two distinct active electrode areasor zones 32 and 34 that are isolated from each other by an electricalisolation zone 36. Electrodes 22 and 24, and zones 32 and 34, areelectrically coupled, such as by an embedded lead wire 38, or by aflexible circuit board, electrical substrate, or other similarstructure. The size, shape, and configuration of structure 30; zones 32,34, and 36; and lead wire 38 can vary from the embodiment depicted inFIG. 2. For example, structure 30 and the relative placement of zones 32and 34, and accordingly zone 36 and lead wire 38, can be customized fora particular treatment area of the body, offered in a range of sizes,and the like. Device 20 also includes a control module 40 comprisinginternal control circuitry, which will be described in more detail belowwith reference to other figures and embodiments of the invention thatinclude similar features.

Referring again to FIG. 1 in addition to FIG. 2, device 20 is aTENS-based stimulator in one embodiment and comprises stimulationcontrol circuitry internal to a control module 40. In the embodiments ofFIGS. 1 and 2, control module 40 is embedded in first electrode 22 andzone 32. It will be appreciated by those skilled in the art that controlmodule 40 can be embedded in or coupled to either or both electrodes 22and 24 or zones 32 and 34. In other preferred embodiments of theinvention, device 20 delivers electrical stimulation modalities otherthan TENS, for example massage, muscle stimulation, cartilage growthstimulation, bone growth stimulation, and other therapeutic treatments.Embodiments of device 20 can also be used in the aid and treatment ofchronic conditions, such as arthritis. Device 20 can also help stimulateblood flow and therefore can be an aid in reduced mobility environments,such as long plane trips, or in recovery from surgery or injury. Controlmodule 40 includes an electrical stimulation signal generator andassociated circuitry (internal as viewed in FIGS. 1 and 2) to generate,control, monitor, and deliver electrical stimulation treatment to auser. Embedding control module 40 into one of electrodes 22 and 24 orzones 32 and 34 provides a small, compact electrical stimulation device20 that is more convenient and less obtrusive than other electricalstimulators.

In another embodiment, a portion of control module 40 is embedded in orcoupled to one or both of electrodes 22 and 24, while another portion isremoved from electrodes 22 and 24 to operate as a wireless remotecontrol. Such a configuration can be especially convenient when device20 is to be positioned in an awkward or hard-to-reach part of the body.Control module 40 can also be adapted or customized for particularapplications. For example, in one embodiment control module 40 furthercomprises a heart rate monitor or other body feedback indicator.

Device 20 further comprises a power source (internal), for example oneor more coin-type batteries. The power source(s) can be included withincontrol module 40, or remote from control module 40 and housed internalto second electrode 24 or zone 34, or first electrode 22 or zone 32 inanother embodiment. For example, as depicted in FIG. 3, a power source42 is embedded within a first electrode 22, and control module 40 iscoupled to a second electrode 24, connected by lead wire 26. Theexterior coupling of control module 40 to electrode 24, rather thanembedding, is described in more detail below. Power source 42 can besingle use and non-replaceable, with device 20 fully disposable upondepletion of power source 42, although in other embodiments device 20 islimited use, capable of being reapplied for subsequent use(s) untillimited-capacity power source 42 is fully depleted. In otherembodiments, power source 42 is rechargeable and/or replaceable. Powersource 42 can comprise a battery, such as a rigid or supple lithiumbattery, coin battery, or other cell.

In one preferred embodiment, neither control module 40 nor the powersource(s) 42 are user accessible, improving the operational integrity ofdevice 20 and providing an elevated level of safety to a user. Device 20can further be made tamper-evident, rendering device 20 inoperative if auser attempts to access control circuitry 40 and/or power source 42 orto otherwise alter the general operation or configuration of device 20.

In one embodiment, device 20 is programmed to automatically commencetreatment upon affixation to the skin of a user. A preprogrammedtreatment program in control module 40 according to this embodimentgradually increases stimulation intensity to a predefined fixed maximumlevel and maintains electrical stimulation therapy until the device isremoved from a user's skin or a power source is fully depleted. In oneembodiment, the gradual intensity increase to a maximum intensity takesplace over a period of about one to several minutes, more specificallyabout two minutes. The power source can comprise at least onenon-replaceable battery embedded in one or both of the electrodes andhas an expected life in continuous use of about twelve hours. Otherpower sources can be used and selected to maximize a desired treatmentthat may be customized to deliver a longer, shorter, more intense, orless intense stimulation program. After treatment, the electricalstimulation device is partially or completely disposable. For example,control module 40 may be reusable while electrodes 22 and 24 are singleuse and disposable.

Referring to FIGS. 3 and 4, device 20 according to another embodiment ofthe invention comprises a control button 44 and a status indicator 46.Control button 44 and status indicator 46 can also be included onstructure 30 (FIG. 2). Control button 44 can comprise an ON/OFF button,an ON/ADJUST/OFF button, a toggle or slide, or some other similarconfiguration. In one preferred embodiment, control button 44 comprisesa single-contact depressible ON/OFF button that operates an embeddedcontact or switch. In this embodiment, device 20 is powered on bydepressing button 44 a first time and instantly powered off bydepressing button 44 a second time. In one embodiment, control button 44is recessed to prevent accidental activation and also to prevent anymetallic contact when a user depresses button 44.

In another preferred embodiment, control button 44 comprises asingle-contact ON/ADJUST/OFF button. In this embodiment, a firstdepression of the button powers on device 20, a second maintaineddepression increases or otherwise adjusts a stimulation intensitydelivered by device 20, and a third depression powers off device 20.When device 20 is powered on and ON/ADJUST/OFF button 44 is held, thestimulation intensity increases until button 44 is released, up to apreset maximum.

In yet another preferred embodiment, control button 44 comprises a dual-or multi-contact toggle button. The toggle button can be used to powerdevice 20 on and off and to increase or decrease stimulation intensity.When electrical stimulation device 20 is powered on and toggle button 44of this embodiment is depressed, the stimulation intensity stepincreases to a preset maximum or step decreases to a preset minimum witheach depression.

Referring to the embodiment of FIG. 5, device 20 comprises a firstcontrol button 48 and a second control button 50. First control button48 is an ON/UP adjustment input and second control button 50 is anOFF/DOWN adjustment input, although the particular functions of eachfirst control button 48 and second control button 50 can be reversed, oranother configuration can be programmed and implemented. As depicted,button 48 is similar in configuration to control button 44, while button50 is a ring-type push-activated structure. This dual-function keypad ishelpful when device 20 is placed on areas of the body where line ofsight is not available, providing an easy way for a user to tactilelydifferentiate between buttons 48 and 50 to increase or decrease astimulation intensity or change an operational state of device 20. Incontrast, if a single toggle button is implemented and a user cannot seean orientation of device 20 in order to visually determine which side ofthe toggle to depress, the user may inadvertently increase thestimulation intensity by depressing the wrong side when instead he orshe desired to decrease the intensity.

In another embodiment, the dual-function keypad depicted in FIG. 5 canbe integrated into a single piece, flexible button. Referring to FIG. 6,an alternate embodiment of control module 40 incorporates a single,dual-function flexible keypad 52. Dual-function keypad 52 comprises afirst inner zone 54 (analogous to button 48 of FIG. 5) and a secondouter zone 56 (analogous to button 50 of FIG. 5). Control module 40comprising dual-function keypad 52 as depicted in FIG. 6 can besubstituted for the embodiment of control module 40 depicted in FIG. 3,for example. Zones 54 and 56 can be programmed according tofunctionality that is the same as or similar to that of buttons 48 and50 described above with reference to FIG. 5. Flexible keypad 52 makesmore convenient the placement and operation of device 20.

FIGS. 7A-7F depict additional alternate embodiments of device 20 andcontrol buttons 34 and 36. As in the embodiment depicted in FIG. 3,device 20 of FIGS. 7A-7F comprises control module 40 coupled to asurface of one of electrodes 22 and 24, rather than being embeddedwithin electrode 22 or 24. In one embodiment, a portion of controlmodule 40 is embedded within electrode 22 or 24, while a remainder ofcontrol module 40 is mechanically and electrically coupled to electrode22 or 24 and the embedded circuitry.

Referring to FIG. 7A, device 20 comprises first and second electrodes 22and 24, control module 40, and lead wire 26 coupling control module 40and first electrode 22 to second electrode 24. Power source 42 (notshown) can be included within control module 40, or embedded within oneof electrodes 22 or 24 or a connector 58, which mechanically andelectrically couples lead wire 26 to electrode 24 and is described inmore detail below. As depicted, connector 58 can include strain reliefmeans to make more convenient the positioning of electrode 22 relativeto electrode 24. In another embodiment, power source 42 can comprise twoor more separate batteries or other power supplies, with individualbatteries embedded within one or more of electrodes 22 and 24, controlmodule 40, and connector 58.

Control module 40 as depicted in FIG. 7A comprises a first ON/INCREASEcontrol button 60 and a second OFF/DECREASE control button 62. Buttons60 and 62 are similar to control buttons 48 and 50 described above.Other button configurations that are tactilely or otherwisedifferentiated when out of sight can also be used, for example oneconvex button and one concave button; two other distinctly shapedbuttons, such as one round button and one square; one or both buttonshaving textured or raised surfaces; two distinct materials, such as oneplastic-like button and one rubber-like button; and the like. Thecontact areas of each of buttons 44, 48, 50, 54, 56, 60 and 62,regardless of configuration, are preferably recessed or raised withrespect to an outer housing or rim of control module 40 and/or anotherbutton for differentiation and to prevent accidental activation,although certain button features may be raised for easieridentification. For example, referring to FIG. 7A, button 50 is raisedwith respect to a housing 64 of control module 40, which button 62 isrecessed. In FIGS. 7B-F, button 60 comprises a raised portion 61 to aidin button identification and differentiation.

In one embodiment, control module 40 further comprises status indicator46. Status indicator 46 preferably provides a visual indication of apower-on state of device 20. In one embodiment, status indicator 46 is alight-emitting diode (LED). Indicator 46 is preferably illuminated,steady or blinking, when the device is powered on and power source 42life exists. Status indicator 46 can be programmed to provide additionalinformation in other embodiments. For example, in embodiments in whichan increased or maximum intensity is blocked by device 20 for an initialwarm-up period, indicator 32 can flash during the warm-up period andthen be illuminated in a steady state to communicate to a user that theintensity may now be selectively increased. In another embodiment,indicator 32 can flash faster or slower according to a stimulationfrequency. In yet another embodiment, control module 40 comprises anaudible status indicator instead of or in addition to status indicator46. Long, short, or steady tones can be used in this embodiment todifferentiate various operating states and conditions.

In alternate embodiments, control module 40 comprises one or moreembedded status indicators instead of or in addition to external statusindicator 46. In these alternate embodiments, all or part of housing 64of control module 40 is transparent or semi-transparent to permitviewing of the embedded status indicator(s). For example, a first statusindicator can be embedded near first control button 60, and a secondstatus indicator can be embedded below second control button 62. Thefirst and second embedded status indicators can then light as eitherfirst control button 60 and second control button 62 are activated. Theembedded status indicators can comprise LEDs in the same or differentcolors to differentiate various operating states or functions of device20. One or more additional embedded status indicators could bepositioned within control module 40 below housing 64 to indicate a lowbattery status, an on or off status, a stimulation frequency orintensity, or some other status, operation, or function. In anotherembodiment, only a single status indicator is embedded within controlmodule 40 to indicate an on or off state of device 20, as describedabove with reference to external indicator 46. Whether embedded orexternal, the single status indicator can also be programmed to flash orchange display intensity according to a stimulation treatment beingdelivered or to otherwise change state according to an operatingcharacteristic of device 20. FIGS. 7B-7F depict alternate embodimentsand configurations of control module 40, control buttons 60 and 62, andstatus indicator 46.

In the embodiments of FIGS. 7A-7F, one or both of electrodes 22 and 24can be removably or permanently coupled to one or both of control module40 and connector 58. Removable couplings enable quick and convenientreplacement of electrodes 22 and 24, while permanent couplings canimprove tamper resistance and security. In one embodiment, a removablecoupling is accomplished by a snap connector. As depicted in FIG. 8A,control module 40 comprises a female snap 66 and electrode 22 comprisesa male snap 68. Snaps 66 and 68 are adapted to be securely yet removablycoupled to each other, providing both mechanical and electricalcouplings between control module 40 and electrode 22.

As depicted in FIG. 8A, electrode 24 comprises embedded power source 42.Alternatively, electrode 24 can comprise a male snap 68 adapted to besecurely yet removably mechanically and electrically coupled with afemale snap 66 on housing 58 (refer also to FIGS. 7A-7F), as depicted inFIG. 8B. In this embodiment, connector 58 can optionally house powersource 42 or other circuitry or can comprise a simple mechanical andelectrical coupler. Female snap 66 and male snap 68 can also be reversedbetween control module 40 and electrode 22, and between connector 58 andelectrode 24. In one embodiment, snaps 66 and 68 can provide rotationwith respect to one another, eliminating the rigid placement structureof electrodes 22 and 24, control module 40 and lead wire 26 and makingthe positioning of each electrode 22 and 24 on a user's body moreconvenient.

FIGS. 9-10B depict another preferred embodiment of the electricalstimulation device of the present invention. FIG. 9 is a cross-sectionalview of a rotating control module 70, similar to control module 40above. FIGS. 10A and 10B are top and bottom views, respectively, ofcontrol module 70. Control module 70 comprises an upper housing 72 and alower cover 74 substantially enclosing and protecting control circuitry.Both upper housing 72 and lower cover 74 preferably comprise plastic,textured or coated for improved grip and appearance. The controlcircuitry within control module 70 comprises a printed circuit board 76on which a microprocessor and various other electrical components aremounted. A barb rivet 78 can be push-locked to secure upper housing 72,printed circuit board 76, and lower cover 74, and in one embodiment ispermanent to prevent a user from accessing or tampering with theinternal circuitry. Bottom cover 74 comprises a center snap 80 adaptedto interconnect with barb rivet 78. Center snap 80 is preferablysectioned or divided about its circumference to provide adequate flex ofthe snap feature to interlock with a lower barb 82 of barb rivet 78.Barb rivet 78 secures upper housing 72 to each printed circuit board 76and lower cover 74 such that upper housing 72 can rotate about barbrivet 78 relative to printed circuit board 76 and lower cover 74. Bottomcover 74 further comprises a second snap portion 84 adapted to removablycouple printed circuit board 76 to an electrode (not shown) to deliverelectrical stimulation signals and permit replacement of new and usedelectrodes.

Control module 70 further comprises an internal switch 86 coupled toupper housing 72. In one embodiment, internal switch 86 comprises afoam-filled conductive fabric adhesively secured (78) to upper housing72, although other switch types and configurations, and other securingmeans 88 can be used in other embodiments. For example, internal switch86 can be glued to upper housing 72. Internal switch 72 is configuredand placed to activate contacts 90 distributed on printed circuit board76 when upper housing 72 is rotated relative to printed circuit board76. Each contact 90 can initiate a different action by the internalcircuitry, including ON, OFF, INTENSITY ADJUST UP, INTENSITY ADJUSTDOWN, and others. Multiple unique actions are thereby made possiblethrough a simple rotating motion.

In one embodiment, upper housing 72 comprises a wire exit aperture 92 tocouple the internal circuitry with an electrode (not shown). A wire orcable passing through wire exit aperture 92 can also provide power if abattery or other power source is located external to control module 70,such as embedded in or mounted on another electrode. In anotherembodiment, bottom cover 74 comprises a wire exit aperture 84 thatpermits uninterrupted rotational freedom of upper housing 72 relative tobottom cover 74.

Bottom cover 74 also can comprise mounting points 96 for printed circuitboard 76 that do not inhibit rotational movement yet secure printedcircuit board 76 and create an air gap within control module 70 forcomponent placement. Mounting points 96 can be molded as part of bottomcover 74, or otherwise secured to both bottom cover 74 and printedcircuit board 76. To further secure printed circuit board 76, uppercover 72 can comprise one or more stop ribs 98. Stop ribs 98 keepprinted circuit board 76 from floating within control module 70 and canalso set limits on rotational motion of upper cover 72 by abuttingcorresponding ribs (not shown) on printed circuit board 76. Stop ribs 98can also be used to create a ratchet effect, locking or free motion, tocontrol and indicate relative rotational placement in use.

Printed circuit board 76 preferably comprises an indicator 100, such asan LED and similar to indicator 46 described above. In one embodiment,indicator 100 visually distinguishes various operating modes or statesby displaying a different color or by blinking. In an embodimentcomprising indicator 100, at least a portion of upper housing 72preferably is transparent or semitransparent to provide control module70 with a glowing effect or to show a non-steady state of indicator 96.

Yet another embodiment of the electrical stimulation device of thepresent invention is depicted in FIGS. 11-14C. Device 20 of FIGS. 11-14Ccomprises a substantially flexible circuit board for even and controlleddistribution of electrical stimulation signals. Referring to FIGS.11-13, a cross-sectional view of a control module 110 similar to controlmodules 40 and 70 described above is shown. Control module 110 comprisesan upper housing 112, a lower cap 114, and a flexible circuit board 116.Upper housing 112 and lower cap 114 substantially enclose circuit board116, with a male snap portion 118 lower cap 114 secured to a female snapportion 120 of upper housing 112. Snap portions 118 and 120 fit securelyyet provide enough clearance for lower cap 114 to freely rotate.

Flexible circuit board 116 comprises a mounting point for the electricalcircuitry and components housed in control module 110 and distributeselectric current to various conductive zones A-P to simulate anelectrode. Each zone A-P is divided into subzones 1-16, and each subzone1-16 of each zone comprises an array of individual contacts 122.Individual contacts 122 provide a plurality of contact points betweendevice 20 and a user's skin. Advantageously, each contact 122, subzone1-16, and zone A-P depicted in FIG. 12 can be monitored, controlled, ordisabled individually, and a more balanced and efficient distribution oftherapeutic current can be provided. Flexible circuit board 116 istherefore an inexpensive alternative to ordinary disposable electrodes.

A conductive electrode adhesive gel 124 can provide adhesion of flexiblecircuit board 116 to a user's skin and can be easily applied from a roll126 having a backing 128. Backing 128 can be used to store adhesive gel124, providing protection from damaging moisture and contamination untiluse. In one embodiment, conductive adhesive gel 124 can be packaged onbacking 128 in precut shapes. After use, adhesive gel 124 can be peeledoff of flexible circuit board 116 and discarded and a new layer 114 canbe applied.

Referring also to FIGS. 14A-14C, flexible circuit board 116 and controlmodule 110 are mounted to a stretch layer 130. Stretch layer 130 cancomprise a fabric or other flexible, elastic material, and flexiblecircuit board 116 and control module 110 can be secured to layer 130 byan adhesive 132. Stretch layer 130 is designed to provide additionallength or to take up any slack in flexible circuit board 116,accommodating various placement distances of the simulated electrodeportions of flexible circuit board 116. For example, an extra length116A of flexible circuit board 116 secured to stretch layer 130 provideseasy adjustment of the individual placement and separation distance oftwo regions of contact zones 122.

Referring now to the various embodiments of FIGS. 1-14C, device 20preferably includes a plurality of selectable intensity settings when inuse, ranging from a preset initial minimum intensity to a presetselectable maximum intensity. In one embodiment, device 20 includesseveral intensity settings selectable via control button(s) 44, 48/50,54/56, or 60/62 or via rotatable control module 40. In anotherembodiment, device 20 provides a continuous ramping up or down ofintensity to a preset maximum. The continuous ramping can be automatic,upon initiation of electrical stimulation or after a preprogrammedperiod of time at a minimum warm-up intensity has passed, or cancommence upon user input to control button(s) 44, 48/50, 54/56, or 60/62or rotatable control module 40, at any time during treatment or after apreprogrammed period of time. The intensity adjustment feature ofcontrol button(s) 44, 48/50, 54/56, and 60/62 and rotatable controlmodule 40 may or may not be included in every embodiment of device 20.

In one embodiment, device 20 is adapted to deliver a one-channel,non-compensated but alternated pulse form output across a 500-Ohm load.Various aspects of device 20, both physical and electrical, can befurther customized for a particular area of the body or stimulationtype. Different varieties of intensity, pulse width, frequency, andother electrical characteristics of the delivered stimulation signalsand different electrode shapes and configurations can be providedaccording to an intended use or application. In any of an automatic,controllable, or other embodiment of electrical stimulation device 20,control modules 40, 70, and 110 can be preprogrammed with one or more ofa variety of electrical stimulation treatment programs.

For example, a TENS-based electrical stimulation treatment program cancomprise a signal frequency modulated from about sixty-five Hertz (Hz)(130 pulses per second) to about one Hz (two pulses per second) and thenback to about 130 Hz with a pulse width of about thirty microseconds ina cycle of about twelve seconds, with a non-linear frequencyprogression. Device 20 can then be customized to include electrodes 22and 24, structure 30, or flexible circuit board 116, of various sizesand configurations. In one embodiment, electrodes 22 and 24 are eachabout four inches long and about two inches wide, or about tencentimeters by about five centimeters, which can be more comfortable forlarger muscle areas such as the back and legs. In another embodiment,electrodes 22 and 24 are each about two inches square, or fivecentimeters by five centimeters, which can be comfortable on other,smaller muscle areas. The overall shape and size of structure 30, oneembodiment of which is depicted in FIG. 2, can vary according to almostany configuration. Other sizes and configurations of electrodes 22 and24 and structure 30 can also be used. The size, shape, and generalconfiguration of flexible circuit board(s) 116 of device 20 can alsovary.

In another exemplary embodiment, device 20 provides therapeutic massageby delivering an electrical stimulation treatment program comprising afrequency of about two Hz, four pulses per second, and a pulse width ofabout 200 microseconds. In this embodiment, device 20 preferablyincludes the smaller sized electrodes 22 and 24 as described above butcan also include the larger or some other electrode size andconfiguration or structure 30.

In other embodiments, other frequencies, pulse widths, pulse numbers,and other electrical characteristics can be implemented, alone or incombination, to achieve desired therapeutic goals. Other physicalcharacteristics of device 20, such as electrode 22 and 24, structure 30,and flexible circuit board 116 configurations, can also be used. Suchcharacteristics, configurations, and variations of the same can beappreciated by those skilled in the art.

Device 20 can therefore be configured and used for drug- andchemical-free TENS-based pain management applications, or fortherapeutic massage, muscle stimulation and contraction, vasculartreatment, and other applications. In one embodiment, the length of leadwire 26 or 38, or flexible circuit board 116, can also be customized tomake it easier to place device 20 on a particular region of the body.Accordingly, various configurations of device 20 can be offered as aseries of customized treatment devices to provide a range of options tousers. These devices 20 can be electrically and physically configuredfor a particular therapeutic treatment and muscle area, then packagedand labeled accordingly for easy identification and selection by a useraccording to his or her treatment needs. A single device, however, canprovide near universal application to all parts of the body in onepreferred embodiment.

In use, electrodes 22 and 24, and/or structure 30 and flexible circuitboard 116, of device 20 are applied to a user's skin proximate a targettissue treatment area. Device 20 can then be powered on via controlbutton(s) 44, 48/50, 54/56, or 60/62, or rotatable control module 40, toprovide electrical stimulation treatment until power source 42 isdepleted or device 20 is selectively removed from the user's skin. Thepower-on and/or operational status of device 20 can be communicated tothe user by indicator 46/100. In one preferred embodiment, device 20, inparticular control module 40/70/110, includes a load contact detectiondevice, which prevents device 20 from delivering stimulation treatmentuntil device 20 is successfully positioned and applied, i.e., bothelectrodes 22 and 24, both zones 32 and 34, or both conductive arrays offlexible circuit boards 116, are properly affixed to a user's skin, andwhich automatically returns a stimulation intensity to zero if one orboth of electrodes 22 and 24, zones 32 and 34, or conductive arrays offlexible circuit boards 116, are separated or removed from a user's skinduring treatment. In the latter situation, indicator 46/100 will remainon but will change status, for example will change from a steady lightedstate to a blinking state, to alert a user. In one preferred embodiment,indicator 40/100 will blink in this state for a limited period of time,such as several seconds to several minutes, more particularly about oneminute, before automatically powering off. In another preferredembodiment, device 20 fully and automatically powers off if one or bothof electrodes 22 and 24 are removed from a user's skin. Device 20 maythen be restarted upon proper reapplication of electrodes 22 and 24.These features thereby improve the safety and power source life ofdevice 20.

In another embodiment as described above, control button(s) 44, 48/50,54/56, or 60/62 is depressed, or rotatable control module 40 is rotated,to power on device 20 after placement and, if available, to select adesired treatment intensity. As previously described, an upper range ormaximum treatment intensity can be blocked for some initial or warm-upperiod of time, for example about one to several minutes, to allow auser to become acclimated to the electrical stimulation withoutover-stimulation. Device 20 can then be worn unobtrusively for a desiredtreatment period, which can be several minutes to several hours or more,while electrical stimulation treatment is continuously provided. In oneembodiment, device 20 provides uninterrupted treatment for one day, orabout twelve hours. Power-on status and/or power source status can bemonitored via indicator 46/100. Treatment can then be selectivelystopped by depressing control button(s) 44, 48/50, 54/56, or 60/62 orrotating rotatable control module 40 and, in one embodiment, device 20can be removed and later reapplied for additional treatment pendingpower source availability. Treatment may therefore be provided inmultiple shorter treatment sessions over a one- or two-day period,according to power source life. Device 20 preferably also includessafety features to prevent electric shock to a user when applying orremoving device 20. When a treatment session is complete and/or thepower source is depleted, device 20 can be removed and fully orpartially disposed. For example, in one embodiment the power source andelectrodes are disposable, while control module 40 is at least partiallyreusable. In other embodiments, device 20 is otherwise partiallydisposable or is alternately completely disposable.

The electrical stimulation device of the present invention is thereforeof benefit in the treatment of nerves, muscles, and other tissues. Invarious embodiments of the invention, the device delivers TENS and/orother electrical stimulation modalities, for example massage, musclestimulation, cartilage growth stimulation, bone growth stimulation, andother therapeutic treatments. Embodiments of the device can also be usedin the aide and treatment of chronic conditions, such as Arthritis, andto help stimulate blood flow. The device therefore can be an aid inreduced mobility environments, such as long plane trips, or in recoveryfrom surgery or injury.

Although specific embodiments have been illustrated and described hereinfor purposes of description of an example embodiment, it will beappreciated by those of ordinary skill in the art that a wide variety ofalternate and/or equivalent implementations calculated to achieve thesame purposes may be substituted for the specific embodiments shown anddescribed without departing from the scope of the present invention.Those skilled in the art will readily appreciate that the invention maybe implemented in a very wide variety of embodiments. This applicationis intended to cover any adaptations or variations of the variousembodiments discussed herein, including the disclosure information inthe attached appendices. Therefore, it is manifestly intended that thisinvention be limited only by the claims and the equivalents thereof.

What is claimed is:
 1. A compact electrical stimulation devicecomprising: a first and a second disposable and self-adhesive electrodeportion; a control module selectively attachable to the first electrodeportion and comprising: at least one preprogrammed treatment programcomprising at least one customizable treatment characteristic; a statusindicator adapted to indicate at least one of a characteristic of thedevice and a characteristic of the preprogrammed treatment program; anda first and a second control input adapted to customize the at least onetreatment characteristic within a predetermined range, the first controlinput tactilely differentiated from the second control input; a flexiblecable coupled at a first end to the control module and selectivelyattachable at a second end to the second electrode portion; and a powersource housed in a structure also having the control module andelectrically coupled to the control module to power the electricalstimulation device.
 2. The compact electrical stimulation device ofclaim 1, wherein the power source is replaceable.
 3. The compactelectrical stimulation device of claim 1, wherein the control module isdisposable when the power source is depleted.
 4. The compact electricalstimulation device of claim 1, wherein the at least one preprogrammedtreatment program is selected from a group consisting of atranscutaneous electrical nerve stimulation (TENS) program, a musclestimulation program, a massage program, a bone growth stimulationprogram, and a cartilage growth stimulation program.
 5. The compactelectrical stimulation device of claim 1, wherein the status indicatorcomprises a light emitting diode (LED).
 6. The compact electricalstimulation device of claim 5, wherein the control module comprises atransparent or semi-transparent housing, and wherein the statusindicator is embedded within the control module housing.
 7. The compactelectrical stimulation device of claim 1, further comprising a strainrelief connector proximate the second end, the strain relief connectorincluding a snap connector selectively attachable to a correspondingsnap connector of the second electrode portion.
 8. The compactelectrical stimulation device of claim 1, wherein the control modulecomprises a snap connector selectively attachable to a correspondingsnap connector of the first electrode portion.
 9. The compact electricalstimulation device of claim 1, wherein the at least one customizabletreatment characteristic comprises a stimulation intensity, and whereinthe predetermined range varies from a preset minimum stimulationintensity to a preset maximum stimulation intensity.
 10. The compactelectrical stimulation device of claim 1, wherein the first and secondcontrol inputs are integrated in a flexible dual-function keypad, andwherein a first zone of the keypad comprises the first control input anda second zone of the keypad comprises the second control input.
 11. Thecompact electrical stimulation device of claim 10, wherein the firstzone comprises a depressible outer ring portion of the keypad and thesecond zone comprises a depressible inner button portion of the keypad.12. A compact and disposable electrical stimulation device comprising: afirst and a second disposable and self-adhesive electrode portion; acontrol module integrated with the first electrode portion andcomprising: at least one preprogrammed treatment program comprising atleast one customizable treatment characteristic; and a first and asecond control input adapted to customize the at least one treatmentcharacteristic within a predetermined range, the first control inputtactilely differentiated from the second control input; a flexible cablecoupled at a first end to the control module and at a second end to thesecond electrode portion; and a power source electrically coupled withthe control module and integrated with one of the first or secondelectrode portions.
 13. The compact electrical stimulation device ofclaim 12, wherein the at least one preprogrammed treatment program isselected from a group consisting of a transcutaneous electrical nervestimulation (TENS) program, a muscle stimulation program, a massageprogram, a bone growth stimulation program, and a cartilage growthstimulation program.
 14. The compact electrical stimulation device ofclaim 12, wherein the control module further comprises a statusindicator adapted to indicate at least one of a characteristic of thedevice and a characteristic of the preprogrammed treatment program. 15.The compact electrical stimulation device of claim 14, wherein thestatus indicator comprises a light emitting diode (LED).
 16. The compactelectrical stimulation device of claim 12, wherein the first and secondelectrode portions are coupled together by an integral electricalisolation portion.
 17. The compact electrical stimulation device ofclaim 16, wherein the flexible cable is embedded within the first andsecond electrode portions and the isolation portion.
 18. A compactelectrical stimulation device comprising: a first and a secondself-adhesive electrode portion; a control module selectively attachableto the first electrode portion and comprising: at least onepreprogrammed treatment program comprising at least one customizabletreatment characteristic; a status indicator adapted to indicate atleast one of a characteristic of the device and a characteristic of thepreprogrammed treatment program; and a first and a second control inputadapted to customize the at least one treatment characteristic within apredetermined range, the first control input tactilely differentiatedfrom the second control input; a flexible cable coupled at a first endto the control module and at a second end to the second electrodeportion; and a power source electrically coupled to the control moduleby the flexible cable.
 19. The compact electrical stimulation device ofclaim 18, wherein the power source is integrated in the second electrodeportion.